U.S. patent application number 11/237895 was filed with the patent office on 2006-03-30 for device for treating a patent foramen ovale.
This patent application is currently assigned to Terumo Kabushiki Kaisha. Invention is credited to Yukitoshi Kato.
Application Number | 20060069408 11/237895 |
Document ID | / |
Family ID | 36100272 |
Filed Date | 2006-03-30 |
United States Patent
Application |
20060069408 |
Kind Code |
A1 |
Kato; Yukitoshi |
March 30, 2006 |
Device for treating a patent foramen ovale
Abstract
A device for treating a patent foramen ovale has a first part
having a predetermined length; a second part having a predetermined
length; a third part having a predetermined length; and a pulling
member which penetrates into the second part from a side face of a
distal portion of the second part, crosses the second cylindrical
part obliquely and extends from a side face of a proximal portion
of the second part and penetrates into the third part from a side
face of a distal portion of the third part, with one end of the
pulling member held by a proximal portion of the first part. A part
of a locking mechanism provided at other end of the pulling member
and a part of the locking mechanism provided at the third part are
locked to each other, when the pulling member is pulled to allow
the first part and the second part proximate to each other and the
second part and the third part to be proximate to each other.
Inventors: |
Kato; Yukitoshi;
(Kanagawa-ken, JP) |
Correspondence
Address: |
BUCHANAN INGERSOLL PC;(INCLUDING BURNS, DOANE, SWECKER & MATHIS)
POST OFFICE BOX 1404
ALEXANDRIA
VA
22313-1404
US
|
Assignee: |
Terumo Kabushiki Kaisha
Tokyo
JP
|
Family ID: |
36100272 |
Appl. No.: |
11/237895 |
Filed: |
September 29, 2005 |
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/00606
20130101; A61B 2017/0496 20130101; A61B 2017/00619 20130101; A61B
2017/00623 20130101; A61B 2017/00588 20130101; A61B 2017/00575
20130101; A61B 17/0057 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Foreign Application Data
Date |
Code |
Application Number |
Sep 29, 2004 |
JP |
2004-285236 |
Claims
1. A device for treating a patent foramen ovale comprising: a first
part having a predetermined length; a second part having a
predetermined length; a third part having a predetermined length; a
pulling member penetrating into said second part from a side face
of a distal portion of said second part, crossing said second part
and extends from a side face of a proximal portion of said second
part, and penetrating or being penetrable into said third part from
a side face of a distal portion of said third part, with one end of
said pulling member held by said first part, and a pair of a
locking mechanism provided at other end of said pulling member and
said third part being locked to each other, when said pulling
member is pulled to allow said first part and said second part to
proximate to each other and said second part and said third part to
be proximate to each other.
2. A device according to claim 1, wherein said first part is a
first cylindrical or columnar part; said second part is a second
cylindrical or columnar part; and said third part is a third
cylindrical or columnar part.
3. A device according to claim 1, said device comprising: a first
connection portion bendably connecting a proximal end of said first
part and a distal end of said second part to each other; and a
second connection portion bendably connecting a position, located
at a proximal end of said second part, which obliquely confronts
said first connection portion and a distal end of said third part
to each other, wherein said one end of said pulling member held at
a position of said first part in the vicinity of said first
connection portion, said pulling member penetrates into said second
part from a position of said side face of said distal portion of
said second part in the vicinity of said first connection portion,
extends from a position of said side face of said proximal portion
of said second part in the vicinity of said second connection
portion, and penetrates into said third part from a position of
said side surface of said distal portion of said third part in the
vicinity of said second connection portion.
4. A device according to claim 1, wherein said locking mechanism
comprises an anchoring portion provided at said other end portion
of said pulling member; and a locking portion, provided at said
third part, which permits a passage of said anchoring portion and
locks said anchoring portion thereto after said anchoring portion
passes therethrough.
5. A device according to claim 4, wherein said anchoring portion is
provided plurally along said pulling member.
6. A device according to claim 4, wherein said locking portion is
composed of a side hole permitting a passage of said anchoring
portion and locking said anchoring portion thereto after said
anchoring portion passes therethrough.
7. A device according to claim 4, wherein said locking portion is
provided plurally along an axial direction of said third part.
8. An apparatus, for treating a patent foramen ovale, which is
formed on a septum in an organism, comprising: an outer tube; a
device, according to claim 1, accommodated inside a distal portion
of said outer tube with said device kept almost straight; an inner
tube for pressing said device out of a distal end of said outer
tube; and a pulling wire for pulling said pulling member separably
from said pulling wire.
9. An apparatus according to claim 8, wherein said pulling member
of said device has an annular portion at a proximal end thereof;
and said pulling wire is folded back after said pulling wire
penetrates through said annular portion.
10. An apparatus according to claim 8, further comprising an
unlocking mechanism for releasing locking performed by said locking
mechanism of said device.
11. An apparatus according to claim 10, wherein said unlocking
mechanism is composed of an unlocking wire, having a loop, which is
disposed in said apparatus; and said pulling member or said pulling
wire penetrates through said loop of said unlocking wire.
12. A device for treating a patent foramen ovale comprising: a
first part having a predetermined length and a through-passageway
provided at a proximal side thereof; a second part having a
predetermined length and a through-passageway; a third part having
a predetermined length and a through-passageway provided at a
distal side thereof; a pulling member, one end of which is held by
said first part and which is extended sequentially in penetration
through said through-passageway of said first part, said
through-passageway of said second part, and said through-passageway
of said third part; and a deformed state holding member, provided
at other side of said pulling member, for holding said device
deformed into an approximately Z configuration, in a side view,
which is formed by approach or contact of a side face of a proximal
portion of said first part to or with a side face of a distal
portion of said second part at one side thereof owing to pulling of
said pulling member and approach or contact of a side face of a
proximal portion of said second part at other side thereof to or
with a side face of a distal portion of said third part owing to
pulling of said pulling member.
13. A device according to claim 12, wherein said second part can be
bent at said proximal portion of said first part, and said third
part can be bent at said proximal portion of said second part.
14. A device according to claim 12, further comprising an
integrally formed body member having said first part, said second
part and said third part, wherein said body member has a first
connection portion bendably connecting said first part and said
second part with each other and a second connection portion
bendably connecting said second part and said third part with each
other.
15. A device according to claim 12, wherein one end of said pulling
member is held by said first part at a distal portion thereof.
16. A device according to claim 12, wherein said first part said
second part, and said third part are pillar-shaped.
17. A device according to claim 12, wherein a through-passageway of
said second part is provided at a central side of said second
part.
18. A device according to claim 12, wherein said first part
branches toward a distal side thereof; and two branched portions
can be approached to each other.
19. A device according to claim 18, wherein said pulling member
comprises a first pulling member held at a distal portion of each
of said two branched portions of said first part and a second
pulling member which is capable of pulling a proximal side of said
first pulling member and extended sequentially in penetration
through a through-passageway of said first part a
through-passageway of said second part, and a through-passageway of
said third part.
20. A device according to claim 12, wherein said third part
branches toward a proximal side thereof; and two branched portions
can be approached to each other.
21. A device according to claim 12, wherein said deformed state
holding member has a through-hole through which said pulling member
can be slidably penetrated at a predetermined resistance, is
capable of sliding along said second pulling member by being
pressed rearward or forward at a degree of force higher than a
predetermined degree of force, and is not moved by being subjected
to a frictional resistance of said pulling member and that of an
inner surface of said through-passageway in a normal state.
22. A device according to claim 12, further comprising an anchoring
portion provided at other side of said pulling member; and said
deformed state holding member has a locking portion which is
capable of locking said anchoring portion thereto and allows said
pulling member to slide therethrough.
23. A device according to claim 12, wherein said third parts has a
second through-passageway disposed at a proximal side thereof with
respect to said through-passageway formed at a distal side of said
third part, said device further comprising a linear wire for said
third part having a distal-side portion looped at a portion, of
said pulling member, which is disposed between said
through-passageway of said third part and said deformed state
holding member and a proximal side portion which penetrates through
said second through-passageway of said third part and is held at a
proximal portion of said third part.
24. An apparatus for treating a patent foramen ovate comprising: an
outer tube; a device, according to claim 12, which is accommodated
inside a distal portion of said outer tube with said device kept
almost straight; an inner tube for pressing said device out of a
distal end of said outer tube and operating a deformed state
holding member; and a pulling wire which is capable of pulling said
pulling member and separable from said pulling member.
25. An apparatus according to claim 24, wherein a pulling member of
said device for treating a patent foramen ovale has a looped
portion or an annular portion formed at a proximal portion thereof;
and said pulling wire is folded back after said pulling wire
penetrates through said looped portion or said annular portion.
26. An apparatus according to claim 24, further comprising a pulled
state release member which is pulled to move said deformed state
holding member to other side of said pulling member.
27. An apparatus according to claim 26, wherein said pulled state
release member is a looped linear wire looped at a portion, of said
pulling member, which is disposed between said through-passageway
of said third part and said deformed state holding member and
extends to a proximal side of said third part.
28. An apparatus according to claim 24, wherein said third parts
has a second through-passageway disposed at a proximal side thereof
with respect to said through-passageway formed at a distal side of
said third part, said device further comprising a linear wire for
said third part having a distal-side portion looped at a portion,
of said pulling member, which is disposed between said
through-passageway of said third part and said deformed state
holding member and a proximal side portion which penetrates through
said second through-passageway of said third part and is held at a
proximal portion of said third part and said pulled state release
member is a linear wire for pulling a portion, of said linear wire
for said third part which is held by said third part at a proximal
portion thereof.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to a device and an apparatus
for treating a patent foramen ovate by preventing an over-flap of
the patent foramen ovate of a heart septum.
[0002] The foramen ovale is present in the interatrial septum. The
foramen ovale works as a valve in a fetal heart Under normal
conditions, the foramen ovale closes a few months after birth. The
case in which the foramen ovate does not close after birth is
called the patent foramen ovate. About 20% of adults have the
patent foramen ovale. In a normal heart the internal pressure of
the left atrium of heart is higher than that of the right atrium of
heart, and the septum primum covers the foramen ovale as a valve.
Therefore blood does not flow from the left atrium of heart to the
right atrium of heart However, when the internal pressure of the
right atrium of heart becomes higher than that of the left atrium
of heart when a person becomes tense, the septum primum opens
toward the left atrium of heart Thereby the blood flows from the
right atrium of heart to the left atrium of heart When a thrombus
is contained in venous blood flowing from the right atrium of heart
to the left atrium of heart, the thrombus flows in the order of
left atrium of heart.fwdarw.left ventricle.fwdarw.main
artery.fwdarw.brain. Therefore the patent foramen ovale is said to
be a cardiogenic factor of cerebral stroke and migraine.
[0003] The following treatments for the patent foramen ovate are
performed: medicinal therapy (aspirin, warfarin), sealing surgery
to be performed by using percutaneous catheter procedure, and open
heart surgery to be performed by using extracorporeal
circulation.
[0004] The medicinal therapy is the first-choice treatment for the
patent foramen ovale. But it is difficult to control a dose and
stop bleeding during administration. The percutaneous catheter
procedure and the open heart surgery are invasive, but radical,
thus giving no anxiety for a return. In the present stage, the open
heart surgery is more reliable than the percutaneous catheter
procedure in terms of the procedure of sealing the patent foramen
ovale. But considering risks in performing the extracorporeal
circulation and an invasion in incising skin, the percutaneous
catheter procedure is more desirable than the open heart surgery if
the percutaneous treatment provides an effect similar to that
provided by the open heart surgery.
[0005] The device, for sealing the patent foramen ovale, which uses
the percutaneous catheter procedure is retained at the portion of a
congenital septal defect More specifically, to seal a hole in the
septum, the procedure of retaining two disk-shaped films at the
left atrium of heart and the right atrium of heart is adopted to
sandwich the hole.
[0006] In the case of the cerebral stroke and the migraine, it is
unnecessary to use the film to seal the septum primum which is
usually sealed. In this case, it is possible to simplify the
construction of the device. Retaining the device to cover the
defect at the left atrium of heart and the right atrium of heart
causes the thrombus to attach to the left atrium of heart and the
like because the device has a large area. Thereby there is a
possibility that the thrombus formed at the left atrium of heart
causes a patient to have the cerebral stroke and that the device
damages the thin septum primum. Thus there is a demand for
development of a device of specific use.
[0007] To seal a hole of congenital diseases such as atrial septal
defect (ASD), ventricular septal defect (VSD), and patent ductus
arteriosus (PDA), the material for sealing septal defect is
disclosed in EP1222897. The material for sealing septal defect is
applicable to the patent foramen ovale. In using the material for
sealing septal defect, the member is inserted into the hole by
passing the member through the flap which is usually sealed. Thus
there is a possibility that the frail septum primum is broken.
Further because the member has a large area, there is a possibility
that the thrombus attaches to the left atrium of heart or is
discharged therein. Thus it is necessary to perform antiplatelet
treatment to prevent the generation of the thrombus. As another
problem of the method of using the material for sealing septal
defect a large catheter is used because the disk-shaped material is
accommodated in the catheter by folding it The device developed for
carrying out this method is used specifically for a flap-shaped
patent foramen ovale. Thus the risk of forming the thrombus is
decreased by reducing the size of the member to be retained in a
portion to be cured. When this method is used to perform
antiplatelet treatment, effects such as reduction of a treatment
period of time and a dose can be expected. Further it is possible
to reduce the size of the catheter.
[0008] The clip-type device for sealing the patent foramen ovale
for locking the flap is disclosed in U.S. patent Publication
No.2003/225421. In this device, the member shaped by using the
material having a spring action is accommodated in the catheter by
folding it. Folding the member to make the catheter small causes an
excessive load to be applied to a bent portion. Thereby there is a
possibility that the member loses the spring action and gives
damage to the flap.
[0009] The device for sealing the patent foramen ovate is disclosed
in WO2002/098298. The device nay also give damage to the flap.
[0010] It is an object of the present invention to provide an
apparatus including a device, for treating a patent foramen ovate,
which little damages a septum primum (flap) usually sealing the
foramen ovale and little applies a load thereto, restrains the flap
from opening toward the left atrium of heart, and is capable of
preventing blood from flowing from the right atrium of heart to the
left atrium of heart in spite of a patent foramen ovale.
SUMMARY OF THE INVENTION
[0011] The object described above is attained by the following a
centrifugal fluid pump apparatus.
[0012] A device for treating a patent foramen ovale comprises a
first part having a predetermined length, a second part having a
predetermined length, a third part having a predetermined length, a
pulling member penetrating into said second part from a side face
of a distal portion of said second part, crossing said second
cylindrical part obliquely and extends from a side face of a
proximal portion of said second part, and penetrating or being
penetrable into said third part from a side face of a distal
portion of said third part, with one end of said pulling member
held by said first part, and a pair of a locking mechanism provided
at other end of said pulling member and said third part being
locked to each other, when said pulling member is pulled to allow
said first part and said second part to proximate to each other and
said second part and said third part to be proximate to each
other.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is an outlook view of one embodiment of an apparatus,
for treating a patent foramen ovale, including a device of the
present invention for treating the patent foramen ovale.
[0014] FIG. 2 is a partly omitted enlarged sectional view of the
apparatus shown in FIG. 1.
[0015] FIG. 3 is a partly enlarged sectional view of the apparatus
shown in FIG. 1.
[0016] FIG. 4 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale.
[0017] FIG. 5 is a partly enlarged sectional view of the apparatus
shown in FIG. 4.
[0018] FIG. 6 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale.
[0019] FIG. 7 is a partly enlarged sectional view of the apparatus
shown in FIG. 6.
[0020] FIG. 8 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale.
[0021] FIG. 9 is a partly enlarged outlook view of the device shown
in FIG. 8.
[0022] FIG. 10 is a sectional view taken along a line A-A of FIG.
9.
[0023] FIG. 11 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale.
[0024] FIG. 12 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 1 through 3.
[0025] FIG. 13 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 1 through 3.
[0026] FIG. 14 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 1 through 3.
[0027] FIG. 15 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 1 through 3.
[0028] FIG. 16 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 1 through 3.
[0029] FIG. 17 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 1 through 3.
[0030] FIG. 18 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 8 through 10.
[0031] FIG. 19 is a front view of a device of another embodiment of
the present invention for treating the patent foramen ovale.
[0032] FIG. 20 is a rear view of the device shown in FIG. 19.
[0033] FIG. 21 is a right side view of the device shown in FIG.
19.
[0034] FIG. 22 is a side view of a device of another embodiment of
the present invention for treating the patent foramen ovale.
[0035] FIG. 23 shows an outlook of the apparatus having the device
of the present invention for treating the patent foramen ovale
shown in FIG. 19.
[0036] FIG. 24 is a partly omitted enlarged sectional view of the
apparatus shown in FIG. 23.
[0037] FIG. 25 is an explanatory view for explaining the operation
of the apparatus shown in FIGS. 23 and 24.
[0038] FIG. 26 is an explanatory view for explaining an example of
a deformed state holding member of the device of the present
invention for treating the patent foramen ovale.
[0039] FIG. 27 is an explanatory view for explaining another
example of the deformed state holding member of the device of the
present invention for treating the patent foramen ovale.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0040] The embodiments of a device of the present invention for
treating a patent foramen ovale and an apparatus of the present
invention for treating the patent foramen ovale will be described
below with reference to drawings.
[0041] FIG. 1 is an outlook view of one embodiment of an apparatus,
for treating a patent foramen ovale, including a device of the
present invention for treating the patent foramen ovale. FIG. 2 is
a partly omitted enlarged sectional view of the apparatus shown in
FIG. 1. FIG. 3 is a partly enlarged sectional view of the apparatus
shown in FIG. 1.
[0042] A device 1 for treating the patent foramen ovale
(hereinafter often referred to as merely device 1) formed on a
septum in an organism (in other words, a heart of human) has a
first part 2 having a predetermined length; a second part 3 having
a predetermined length; a third part 4 having a predetermined
length; and a pulling member 5 which penetrates into the second
part 3 from a side face of a distal portion of the second part 3,
crosses the second cylindrical part 3 obliquely and extends from a
side face of a proximal portion of the second part 3, and
penetrates or is penetrable into the third part 4 from a side face
of a distal portion of the third part 4, with one end of the
pulling member 5 held by the first part 2. A part of a locking
mechanism provided at other end of the pulling member 5 and a part
of the locking mechanism provided at the third part 4 are locked to
each other, when the pulling member 5 is pulled to allow the first
part 2 and the second part 3 to be proximate to each other and the
second part 3 and the third part 4 to be proximate to each other.
In other words, the device 1 for treating the patent foramen ovale
has a pair of the locking mechanism provided at other end of the
pulling member 5 and the third part 4. The locking mechanism of the
pulling member 5 and the locking mechanism of the third part 4 are
locked to each other. Further in other words, the device 1 for
treating the patent foramen ovale has a pair of the locking
mechanism which comprises one of a part provided at the end of the
pulling member 5 and the other of a part provided at the third part
4.
[0043] It is preferable that the first part is a first cylindrical
or columnar part that the second part is a second cylindrical or
columnar part, and that the third part is a third cylindrical or
columnar part.
[0044] It is preferable that the device 1 has a first connection
portion 21 bendably connecting a proximal end of the first part 2
and a distal end of the second part 3 to each other; and a second
connection portion 22 bendably connecting a position, located at a
proximal end of the second part 3, which confronts the first
connection portion 21 obliquely and a distal end of the third part
4 to each other. It is preferable that with one end of the pulling
member 5 held at a position of the first part 2 in the vicinity of
the first connection portion 21, the pulling member 5 penetrates
into the second part 3 from a position of the side face of the
distal portion of the second part 3 in the vicinity of the first
connection portion 21, extends from a position of the side face of
the proximal portion of the second part 3 in the vicinity of the
second connection portion 22, and penetrates into the third part 4
from a position of the side surface of the distal portion of the
third part 4 in the vicinity of the second connection portion
22.
[0045] The apparatus 10 of the present invention has an outer tube
6, the device 1 accommodated inside a distal portion of the outer
tube 6 with the device 1 kept almost straight an inner tube 7 for
pressing the device 1 out of a distal end of the outer tube 6, and
a pulling wire 8 for pulling the pulling member 5 separably from
the pulling wire 8.
[0046] The apparatus 10 of the embodiment shown in FIGS. 1 through
3 will be described below.
[0047] The apparatus 10 of the embodiment has the outer tube 6, the
device 1, the inner tube 7, and the pulling wire 8 for pulling the
pulling member 5.
[0048] As shown in FIGS. 2 and 3, in the device 1 of this
embodiment, the first part 2, the second part 3, and the third part
4 are constructed of a cylindrical part respectively and connected
with each other. Therefore the device 1 of this embodiment has a
first cylindrical part 2; a second cylindrical part 3; a third
cylindrical part 4; a first connection portion 21 bendably
connecting a proximal end of the first cylindrical part 2 and a
distal end of the second cylindrical part 3 to each other; and a
second connection portion 22 bendably connecting a position,
located at a proximal end of the second cylindrical part 3, which
confronts the first connection portion 21 obliquely and a distal
end of the third cylindrical part 4 to each other. With one end of
the pulling member 5 held at a position of the first cylindrical
part 2 in the vicinity of the first connection portion 21, the
pulling member 5 penetrates into the second cylindrical part 3 from
a position of the side face of the distal portion of the second
cylindrical part 3 in the vicinity of the first connection portion
21, extends from a position of the side face of the proximal
portion of the second cylindrical part 3 in the vicinity of the
second connection portion 22, and penetrates into the third
cylindrical part 4 from a position of the side surface of the
distal portion of the third cylindrical part 4 in the vicinity of
the second connection portion 22. In other words, with one end of
the pulling member 5 held at the proximal portion of the first
cylindrical part 2, the pulling member 5 penetrates into the second
cylindrical part 3 from the side face of the distal portion of the
second cylindrical part 3, crosses the second cylindrical part 3
obliquely and extends from the side face of the proximal portion of
the second cylindrical part 3, and penetrates into the third
cylindrical part 4 from the side face of the distal portion of the
third cylindrical part 4. A part of the locking mechanism provided
at the other end of the pulling member 5 and a part of the locking
mechanism provided at the third cylindrical part 4 are locked to
each other, when the pulling member 5 is pulled to allow the first
cylindrical part 2 and the second cylindrical part 3 to be
proximate to each other and the second cylindrical part 3 and the
third cylindrical part 4 to be proximate to each other.
[0049] More specifically, as shown in FIGS. 2 and 3, the first
cylindrical part (first part) 2 has a side hole 23 disposed at its
proximal portion. A slip-off prevention portion 52 provided at one
end of the pulling member 5 is formed larger than the side hole 23.
Thus when the pulling member 5 is pulled, the slip-off prevention
portion 52 is held by an inner peripheral edge of the side hole 23.
Regardless of whether the slip-off prevention portion 52 is
provided at the one end of the pulling member 5, it may be fixed to
the proximal portion of the first cylindrical part 2.
[0050] As shown in FIGS. 2 and 3, the second cylindrical part
(second part) 3 has a side hole 31 provided at its distal portion
and a side hole 32 provided at its proximal portion. The position
of the side hole 32 and that of the side hole 31 are opposed to
each other obliquely with respect to approximately the center of
the second cylindrical part 3.
[0051] As shown in FIGS. 2 and 3, the third cylindrical part (third
part) 4 has a side hole 41 formed at its distal portion and a
locking side-hole 42 formed at a position opposed to the side hole
41.
[0052] The first cylindrical part 2, the second cylindrical part 3,
and the third cylindrical part 4 have passageways 2a, 3a, and 4a
respectively penetrating through the inside thereof These
cylindrical parts 2, 3, and 4 may have any desired configurations.
They may be circular, elliptic, square pillar-shaped, and the like.
It is preferable that a guide wire can be inserted into the first
cylindrical part 2, the second cylindrical part 3, and the third
cylindrical part 4 when the pulling member 5 is present
therein.
[0053] The outer diameter of each cylindrical part of the device 1
is favorably in the range from 0.1 mm to 5.0 mm and more favorably
in the range from 1.0 mm to 3.0 mm. The inner diameter of each
cylindrical part is favorably in the range from 0.02 mm to 4.9 mm
and more favorably in the range from 0.4 mm to 2.8 mm. The length
of each cylindrical part is favorably in the range from 5 mm to 50
mm and more favorably in the range from 7 mm to 35 mm.
[0054] As the material for forming each cylindrical part (first
part, second part, and third part) of the device, in consideration
of properties (flexibility, hardness, strength, sliding property,
kink resistance, and stretching property) demanded therefor, it is
preferable to selectively use polymers such as polyethylene,
polypropylene, nylon, polyethylene terephthalate,
fluorine-containing polymers (for example, PTFE, and ETFE); and
thermoplastic elastomers. The thermoplastic elastomer includes
synthetic resin of nylon family (for example, polyamide elastomer),
urethane family (for example, polyurethane elastomer), polyester
family (for example, polyethylene terephthalate elastomer), olefin
family (for example, polyethylene elastomer, polypropylene
elastomer); metals highly compatible with organisms such as
titanium, titanium alloy, stainless steel, gold, and platinum.
[0055] It is preferable to treat the inner surface of each
cylindrical part and particularly the inner surface of the second
cylindrical part to enhance the sliding property of the pulling
member. As such treatment, it is possible to adopt a method of
applying or fixing the following hydrophilic polymers to the inner
surface thereof: poly(2-hydroxyethyl methacrylate),
polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl
ether-maleic anhydride copolymer, polyethylene glycol, polyacryl
amide, and polyvinyl pyrrolidone. To enhance the sliding property
of the inner surface of the outer tube and/or the outer surface of
the inner tube, these hydrophilic polymers may be applied or fixed
thereto.
[0056] In the device 1 of this embodiment a part of the locking
mechanism provided at the proximal portion of the pulling member 5
and a part of the locking mechanism provided at the third part 4
are locked to each other, when the pulling member 5 is pulled to
allow the first part 2 and the second part 3 to be proximate to
each other and the second part 3 and the third part 4 to be
proximate to each other. More specifically, the locking mechanism
is constructed of a to-be-locked anchoring portion of the pulling
member 5 and the side hole 42 of the third cylindrical part 4 for
locking the to-be-locked anchoring portion.
[0057] As shown in FIG. 3, the pulling member 5 has a linear
portion 51; a holding portion 52 formed at the distal end of the
linear portion 51 to hold the pulling member 5 at the first
cylindrical part 2; and to-be-locked anchoring portions 53, 54, and
55 disposed at a proximal portion of the linear portion 51 along
the linear portion 51. The linear portion 51 extends to the outside
from the side hole 23 of the first cylindrical part 2, penetrates
into the second cylindrical part 3 from the distal-side side hole
31 of the second cylindrical part 3, extends inside the second
cylindrical part 3, and extends to the outside from the
proximal-side side hole 32 of the second cylindrical part 3. The
to-be-locked anchoring portions 53, 54, and 55 provided at the
proximal portion of the pulling member 5 are disposed outside the
third cylindrical part 4 or a part thereof penetrates into the
third cylindrical part 4 from the distal-side side hole 41 of the
third cylindrical part 4. As shown in FIG. 3, the proximal end of
the pulling member 5 may penetrate into the third cylindrical part
4 from the distal-side side hole 41 of the third cylindrical part 4
or may be disposed on the outer surface of the third cylindrical
part 4.
[0058] As the material for forming the linear portion of the
pulling member and the to-be-locked anchoring portion thereof, it
is possible to use metals such as stainless steel, Ni--Ti alloy,
Cu--Zn alloy, Ni--Al alloy, tungsten, tungsten alloy, titanium,
titanium alloy, cobalt alloy, tantalum; comparatively rigid
polymeric materials such as polyamide, polyimide,
ultra-high-molecular-weight polyethylene, polypropylene,
fluororesin; and a combination of these materials. As the linear
portion 51, a wire or a plurality of twisted wires can be
preferably used. Although not specifically limited, the diameter of
the linear portion is favorably in the range from 0.01 mm to 1.3 mm
and more favorably in the range from 0.1 mm to 0.3 mm.
[0059] In this embodiment, the locking mechanism of the embodiment
is composed of a plurality of the to-be-locked anchoring portions
53, 54, and 55 provided at the other end portion (proximal portion)
of the pulling member 5 and the locking side-hole 42 provided at
the third cylindrical part 4. The locking side-hole 42 has a small
portion permitting a forced passage of the anchoring portion and
locking the anchoring portion thereto after the anchoring portion
passes therethrough More specifically, the locking side-hole 42 has
a small diameter portion whose inner diameter is smaller than the
outer diameter of the anchoring portion. The inner diameter of the
locking side-hole 42 is smallest at its central portion to form the
small-diameter portion. The inner diameter of both sides inward and
outward from the small-diameter portion becomes gradually larger.
Thereby the locking side-hole 42 facilitates the forced passage of
the anchoring portion therethrough and holds the anchoring portion
securely. Although it is preferable that the small diameter portion
has the above-described construction, the small-diameter portion
may be composed of an annular rib or ribs annularly dotted. The
small-diameter portion may be disposed on the inner side of the
locking side-hole 42 or on the outer side thereof.
[0060] In this embodiment the to-be-locked anchoring portions 53,
54, and 55 are provided at the proximal portion of the linear
portion 51 of the pulling member 5 along the linear portion 51. The
to-be-locked anchoring portions 53, 54, and 55 can be locked to the
locking side-hole 42. Thereby by locking the to-be-locked anchoring
portion 54 to the locking side-hole 42, it is possible to shorten
the distance between the first cylindrical part 2 and the second
cylindrical part 3 and the distance between the second cylindrical
part 3 and third cylindrical part 4, compared with the case where
the to-be-locked anchoring portion 53 is locked to the locking
side-hole 42. Similarly by locking the to-be-locked anchoring
portion 55 to the locking side-hole 42, it is possible to shorten
the distance between the first cylindrical part 2 and the second
cylindrical part 3 and the distance between the second cylindrical
part 3 and third cylindrical part 4 to a higher extent, compared
with the case where the to-be-locked anchoring portion 54 is locked
to the locking side-hole 42. Therefore the device of this
embodiment allows adjustment of the distance between the first
cylindrical part 2 and the second cylindrical part 3 and the
distance between the second cylindrical part 3 and third
cylindrical part 4 by selectively locking the to-be-locked
anchoring portion to the locking side-hole in dependence on the
thickness of the flap of the septum primum or the configuration of
the foramen ovale.
[0061] As shown in FIGS. 1, 2, and 3, the outer tube 6 is tubular.
The outer tube 6 is open at its distal and proximal ends. The
opening formed at the distal end of the outer tube 6 functions as a
release opening when the device 1 is retained in a foramen ovale.
The distal portion of the outer tube 6 serves as an accommodation
portion for accommodating the device 1 therein when the device is
straight.
[0062] The outer diameter of the outer tube 6 is favorably in the
range from 0.3 mm to 7.0 mm and more favorably in the range from
1.2 mm to 5.0 mm. The inner diameter of the outer tube 6 is
favorably in the range from 0.2 mm to 6.5 mm. The length of the
outer tube 6 is favorably in the range from 300 mm to 2000 mm and
more favorably in the range from 700 mm to 1500 mm.
[0063] As shown in FIGS. 1 through 3, the inner tube 7 is tubular.
The inner tube 7 is open at its distal and proximal ends. The guide
wire can be inserted through the inner tube 7. The inner tube 7 is
accommodated in the outer tube 6. The distal portion 71 of the
inner tube 7 is capable of contacting the proximal portion of the
device 1. Thus the inner tube 7 is capable of pressing the device 1
from the distal end of the outer tube 6. As shown in FIG. 2, in the
apparatus 10 of this embodiment, the diameter of the distal portion
71 of the inner tube 7 becomes gradually smaller toward its distal
end to allow the distal portion 71 of the inner tube 7 to penetrate
into the proximal portion of the device 1. Provided at the distal
portion 71 of the inner tube 7 is a slit 72 into which an unlocking
wire is inserted. The unlocking wire constructs an unlocking
mechanism for releasing locking performed by the locking mechanism
(described later) of the device 1.
[0064] The outer diameter of the inner tube 7 is favorably in the
range from 0.1 mm to 5.0 mm and more favorably in the range from
1.0 mm to 3.0 mm. The inner diameter of the inner tube 7 is
favorably in the range from 0.05 mm to 4.8 mm. The length of the
inner tube 7 is favorably in the range from 300 mm to 2000 mm and
more favorably in the range from 700 mm to 1500 mm.
[0065] As the material for forming the outer tube 6 and the inner
tube 7, in consideration of properties (flexibility, hardness,
strength, sliding property, kink resistance, and stretching
property) demanded for them, it is preferable to selectively use
polymers such as polyethylene, polypropylene, nylon, polyethylene
terephthalate, fluorine-containing polymers (for example, PTFE, and
ETFE); and thermoplastic elastomers. The thermoplastic elastomer
includes synthetic resin of nylon family (for example, polyamide
elastomer), urethane family (for example, polyurethane elastomer),
polyester family (for example, polyethylene terephthalate
elastomer), olefin family (for example, polyethylene elastomer,
polypropylene elastomer).
[0066] It is preferable to treat the outer surface of the outer
tube 6 to enhance the sliding property thereof. As such treatment
it is possible to adopt a method of applying or fixing the
following hydrophilic polymers to the inner surface thereof:
poly(2-hydroxyethyl methacrylate), polyhydroxyethy acrylate,
hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride
copolymer, polyethylene glycol, polyacryl amide, and polyvinyl
pyrrolidone. To enhance the sliding property of the inner surface
of the outer tube and/or the outer surface of the inner tube, these
hydrophilic polymers may be applied or fixed thereto.
[0067] The apparatus 10 has a pulling wire 8 for pulling the
pulling member. The pulling wire 8 extends from the proximal side
of the apparatus 10 between the inner tube 7 and the outer tube 6.
The distal portion of the pulling wire 8 penetrates into the third
cylindrical part 4 from the locking side-hole 42 of the third
cylindrical part 4. The proximal portion of the pulling wire 8
extends to the outside from the proximal end of the outer tube 6.
The pulling wire 8 is separable from the pulling member. As shown
in FIG. 3, the pulling member 5 of the device 1 has an annular
portion 56 at its proximal end. The pulling wire 8 is folded back
after it penetrates through the annular portion 56. That is, a
looped portion 81 of the pulling wire 8 is in penetration through
the annular portion 56. By pulling the pulling wire 8 (exactly, two
wires), the pulling member 5 is pulled to the proximal side of the
apparatus 10. An operation portion 82 is mounted at the proximal
end (proximal end of two wires) of the pulling wire 8. The pulling
wire 8 is made of a material which can be cut Alternatively the
operation portion 82 can be removed from the pulling wire 8.
Therefore by cutting the pulling wire 8 or removing the operation
portion 82 from the pulling wire 8, the end of the pulling wire 8
is formed or exposed. By pulling the pulling wire 8, the pulling
wire 8 can be separated from the pulling member 5. Instead of the
annular portion 56, the pulling member 5 may have a hole through
which the pulling wire 8 can be inserted.
[0068] The apparatus 10 has the unlocking mechanism for releasing
locking performed by the locking mechanism of the device 1. The
unlocking mechanism of the apparatus 10 is composed of the
unlocking wire 9, having a loop 91, which is disposed in the
apparatus 10. The pulling member 5 of the device 1 or the pulling
wire 8 thereof is in penetration through the loop 91 of the
unlocking wire 9. Thus by pulling the unlocking wire 9 toward the
proximal side of the device 1, with the anchoring portion 53 being
locked to the locking side-hole 42, the anchoring portion 53 is
forcibly passed through the locking side-hole 42 and is returned to
the inside of the third cylindrical part 4. Thereby the anchoring
portion 53 and the locking side-hole 42 are unlocked from each
other. An operation portion 92 is mounted at the proximal end
(proximal end of two wires) of the unlocking wire 9. The unlocking
wire 9 is made of a material which can be cut Alternatively the
operation portion 92 can be removed from the unlocking wire 9.
Therefore by cutting the unlocking wire 9 or removing the operation
portion 92 from the unlocking wire 9, the end of the unlocking wire
9 is formed or exposed. By pulling the unlocking wire 9, the
unlocking wire 9 can be separated from the pulling member or the
pulling wire.
[0069] As the pulling wire and the unlocking wire, a wire or a
plurality of twisted wires can be preferably used. Although not
specifically limited, the diameter of the pulling wire and the
unlocking wire is favorably in the range from 0.1 mm to 1.3 mm and
more favorably in the range from 0.1 mm to 0.3 mm. As the material
for forming the pulling wire and the unlocking wire, it is possible
to use metals such as stainless steel, Ni--Ti alloy, Cu--Zn alloy,
Ni--Al alloy, tungsten, tungsten alloy, titanium, titanium alloy,
cobalt alloy, tantalum; comparatively rigid polymeric materials
such as polyamide, polyimide, ultra-high-molecular-weight
polyethylene, polypropylene, fluororesin; and a combination of
these materials.
[0070] As shown in FIGS. 2, 3, 16, and 17, a contrast portion 61 is
formed at the distal portion of the first cylindrical part 2. A
contrast portion 62 is formed at the proximal portion of the first
cylindrical part 2. A contrast portion 63 is formed at the distal
portion of the second cylindrical part 3. A contrast portion 64 is
formed at the proximal portion of the second cylindrical part 3. It
is preferable to provide both the contrast portions 62 and 63, but
the formation of one of the contrast portion 62 and the contrast
portion 63 may be omitted. A contrast portion 65 is formed at the
distal portion of the third cylindrical part 4. A contrast portion
66 is formed at the proximal portion of the third cylindrical part
4. It is preferable to provide both the contrast portions 64 and
65, but the formation of one of the contrast portion 64 and the
contrast portion 65 may be omitted. In the examples shown in FIGS.
2, 3, 16, and 17, the contrast portions are formed at positions a
little inward from the distal or proximal ends of the cylindrical
parts, but may be formed at the distal or proximal ends of the
cylindrical parts.
[0071] The positions of these contrast portions can be checked by
X-ray contrast and ultrasonic wave contrast. It is preferable to
compose the contrast portion of a ring-shaped wire or a coiled
linear wire. As the material of the contrast portion, gold,
platinum, tungsten, and alloys of these metals, a silver-palladium
alloy can be preferably used. The contrast portion may be made of
the same material as that used for the cylindrical members or a
combination of a contrast substance and a material compatible
therewith. As the contrast substance, it is possible to use X-ray
unpermeable materials such as barium sulfate, bismuth oxide, and
tungsten. A contrast portion (not shown) may be formed at the
distal portion of the outer tube 6. It is possible to form the
contrast portion at the distal portion of the outer tube 6 by a
method similar to the method of forming the above-described
contrast portions.
[0072] An embodiment of an apparatus 20 for treating the patent
foramen ovale having a device for treating the patent foramen ovale
shown in FIG. 4 is described below.
[0073] FIG. 4 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale. FIG. 5 is a partly enlarged sectional view of
the apparatus shown in FIG. 4.
[0074] In the above-described device 1, the first part (first
cylindrical part) 2 and the second part (second cylindrical part) 3
are connected to each other with the first connection portion, and
the second part (second cylindrical part) 3 and the third part
(third cylindrical part) 4 are connected to each other with the
second connection portion. The apparatus 20 is different from the
above-described apparatus 10 in that in a device 11 of this
embodiment, the first part (first cylindrical part) 2, the second
part (second cylindrical part) 3, and the third part (third
cylindrical part) 4 are not connected to one another. In other
words, the first part (first cylindrical part) 2, the second part
(second cylindrical part) 3, and the third part (third cylindrical
part) 4 are separately provided. The other constructions of the
device 11 are similar to those of the device 1 of the
above-described embodiment. Thus the same parts of this embodiment
as those of the above-described embodiment are denoted by the same
reference numerals as those of the above-described embodiment, and
the above-described descriptions are referred to. In the device 11
of this embodiment, the first cylindrical part 2 has an inclined
face 27 formed on a bottom surface of the proximal end thereof in
the vicinity of the proximal-side side hole 23. The second
cylindrical part 3 has an inclined face 37 formed on an upper
surface of the distal end thereof in the vicinity of the
distal-side side hole 31 and an inclined face 38 formed on a bottom
surface of the proximal end thereof in the vicinity of the
proximal-side side hole 32. The third cylindrical part 4 has an
inclined face 47 formed on an upper surface of the distal end
thereof in the vicinity of the distal-side side hole 41. The first
cylindrical part 2 and the second cylindrical part 3 are so
disposed that the inclined face 27 of the first cylindrical part 2
and the inclined face 37 of the second cylindrical part 3 confront
each other. The second cylindrical part 3 and the third cylindrical
part 4 are so disposed that the inclined face 38 of the second
cylindrical part 3 and the inclined face 47 of the third
cylindrical part 4 confront each other. Therefore when the pulling
member 5 is pulled, each cylindrical member can be inclined
easily.
[0075] An embodiment of an apparatus 30 for treating the patent
foramen ovale having a device for treating the patent foramen ovale
shown in FIG. 6 is described below.
[0076] FIG. 6 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale. FIG. 7 is a partly enlarged sectional view of
the apparatus shown in FIG. 6.
[0077] A device 12 of the apparatus 30 is different from the device
I of the apparatus 10 in the inner configuration of the third
cylindrical part 4, the locking mechanism for locking a pulling
member 15 including the form of an anchoring portion 17 to a
locking portion of the third cylindrical part 4, and the unlocking
function. The other constructions of the device 12 are similar to
those of the device 1 of the above-described embodiment Thus the
same parts of this embodiment as those of the above-described
embodiment are denoted by the same reference numerals as those of
the above-described embodiment and the above-described descriptions
are referred to.
[0078] The locking mechanism of the device 30 of this embodiment is
constructed of an anchor 17 of a pulling member 15 and a locking
portion 43 provided on a side face of a second passageway 4b of the
third cylindrical part 4.
[0079] As shown in FIGS. 6 and 7, in the device 12 of the apparatus
30, the third cylindrical part 4 has two lumens extending in
parallel with each other. As described above, a first passageway 4a
serves as a guide wire insertion passageway. Inside the distal
portion of the second passageway 4b, the second passageway 4b has a
locking portion 43 to which the anchoring portion 17 of the pulling
member 15 is locked. In this embodiment, locking portions 43a, 43b,
and 43c are formed at certain intervals along the axial direction
of the second passageway 4b. The locking portions 43a, 43b, and 43c
are constructed of an annular rib respectively. Each of the locking
portions 43a, 43b, and 43c has an annular inclined face for guiding
the anchoring portion 17 whose inner diameter becomes gradually
shorter from its distal side to its proximal side; and an annular
face disposed at the rear end of the annular inclined face and
being orthogonal to the second passageway 4b. The annular face and
the anchoring portion 17 are locked to each other.
[0080] As in the case of the above-described embodiment, the
pulling member 15 has a holding portion formed at the distal end
thereof to hold the pulling member 15 at the first cylindrical part
2. As shown in FIGS. 6 and 7, the pulling member 15 extends to the
outside from the distal-side side hole 23 of the first cylindrical
part 2, penetrates into the second cylindrical part 3 from the
distal-side side hole 31 of the second cylindrical part 3, extends
inside the second cylindrical part 3, extends to the outside from
the proximal-side side hole 32 of the second cylindrical part 3,
penetrates into the third cylindrical part 4 from the distal-side
side hole 41 of the third cylindrical part 4. The proximal portion
of the pulling member 15 is disposed inside the second passageway
4b. The proximal portion of the pulling member 15 may not penetrate
into the third cylindrical part 4 but may be disposed on the outer
surface of the third cylindrical part 4. The anchoring portion 17
of this embodiment has a construction similar to that of an
umbrella rib. More specifically, the proximal end of the anchoring
portion 17 is fixed to the pulling member, and the distal end
thereof is formed as a free end. That is, the anchoring portion 17
is constructed of a plurality of rod-shaped members that can be
folded back toward its distal side. The rod-shaped members extend
radially and obliquely from a given position of the pulling member
15 toward the distal end thereof. Therefore by folding the
anchoring portion 17 toward the distal side thereof, it is capable
of passing through the locking portions 43a, 43b, and 43c. After
passing through the locking portions 43a, 43b or 43c, the anchoring
portion 17 opens (in other words, returns to the open
configuration), and the distal end thereof is locked to the annular
face of the locking portion. An annular portion 18 is provided at
the proximal portion of the pulling member 15. Instead of providing
the pulling member 15 with the annular portion 56, the pulling
member 15 may be so constructed that the anchoring portion 17
thereof has a hole into which the pulling wire 8 can be inserted or
the anchoring portion 17 is pulled by the pulling wire 8. The
locking portion 43 may be constructed of an annular groove instead
of the annular rib.
[0081] Similarly to the above-described apparatus 10, the apparatus
30 of this embodiment has a pulling wire 8 for pulling the pulling
member. In correspondence with the inner construction of the third
cylindrical part 4, the inner tube 7 has two lumens extending
therein in parallel. A guide wire is inserted through a first lumen
corresponding to the first passageway 4a of the third cylindrical
part 4. An unlocking wire 19 and the pulling wire 8 are inserted
through a second lumen corresponding to the second passageway 4b of
the third cylindrical part 4. The pulling wire 8 extends inside the
second lumen of the inner tube 7 and penetrates into the third
cylindrical part 4 from the distal end of the second passageway 4b
of the third cylindrical part 4. The proximal portion of the
pulling wire 8 extends to the outside from the proximal end of the
inner tube 7. The pulling wire 8 is separable from the pulling
member 15. As shown in FIG. 6, the pulling member 15 of the device
12 has the annular portion 18 at its proximal end. The pulling wire
8 is folded back after it penetrates through the annular portion
18. That is, the looped portion 81 of the pulling wire 8 is in
penetration through the annular portion 18. By pulling the pulling
wire 8 (exactly, two wires), the pulling member 15 is pulled to the
proximal side of the apparatus 30. An operation portion 82 is
mounted at the proximal end (proximal end of two wires) of the
pulling wire 8. The pulling wire 8 is made of a material which can
be cut Alternatively the operation portion 82 can be removed from
the pulling wire 8. Therefore by cutting the pulling wire 8 or
removing the operation portion 82 from the pulling wire 8, the end
of the pulling wire 8 is formed or exposed. By pulling the pulling
wire 8, the pulling wire 8 can be separated from the pulling member
15.
[0082] The apparatus 30 has also the unlocking mechanism for
releasing locking performed by the locking mechanism of the device
12. The unlocking mechanism of the apparatus 30 is constructed of
an unlocking shaft 19. The unlocking shaft 19 extends inside the
second lumen of the inner tube 7, and penetrates into the third
cylindrical part 4 from the distal end of the second passageway 4b
of the third cylindrical part 4. The pulling wire 8 is in
penetration through the inside of the unlocking shaft 19. To unlock
the anchoring portion 17 of the pulling member 15 from the locking
portion 43, the pulling wire is pulled to some extent with the
distal portion of the unlocking shaft 19 disposed at the rear end
(proximal side) of the anchoring portion 17 to decrease the
diameter of the anchoring portion 17. Thereafter the unlocking
shaft 19 is pressed toward the distal side of the device 12 to some
extent Thereby the anchoring portion 17 and the locking portion can
be unlocked from each other. The unlocking shaft 19 is removed when
there is no need of unlocking the anchoring portion from the
locking portion.
[0083] Similarly to the embodiment described above with reference
to FIGS. 4 and 5, in the device 12 of this embodiment each
cylindrical part does not necessarily have to be provided with the
connection portion. In this case, it is preferable to form opposed
inclined faces at portions of opposed end faces of each cylindrical
part, similarly to the above-described embodiment described above
with reference to FIGS. 4 and 5.
[0084] An embodiment of an apparatus 40 for treating a patent
foramen ovale having a device for treating the patent foramen ovale
shown in FIG. 8 is described below.
[0085] FIG. 8 is a partly omitted enlarged sectional view of
another embodiment of an apparatus, for treating the patent foramen
ovale, including a device of the present invention for treating the
patent foramen ovale. FIG. 9 is a partly enlarged outlook view of
the device shown in FIG. 8. FIG. 10 is a sectional view taken along
a line A-A of FIG. 9.
[0086] A device 13 of the apparatus 40 is different from the device
1 of the apparatus 10 in the configuration of the third cylindrical
part 4, the locking mechanism for locking a pulling member 25
including the form of an anchoring member 28 to a locking portion
of the third cylindrical part 4, and the unlocking function. The
other constructions of the device 13 are similar to those of the
device 1 of the above-described embodiment Thus the same parts of
this embodiment as those of the above-described embodiment are
denoted by the same reference numerals as those of the
above-described embodiment, and the above-described descriptions
are referred to.
[0087] The locking mechanism of the device 40 of the embodiment is
constructed of the anchor 28 of the pulling member 25 and a locking
portion formed on a groove provided at the side face of the third
cylindrical part 4.
[0088] In a device 13 of the apparatus 40, as shown in FIGS. 8, 9,
and 10, the third cylindrical part 4 has a groove 4d formed on its
side face from its distal portion to its proximal end thereof with
the groove 4d extending axially. In this embodiment a plurality of
locking portions 43a, 43b, and 43c are axially provided on the
inner side face of the groove 4d at certain intervals. Each of the
locking portions 43a, 43b, and 43c is constructed of a pair of
opposed ribs. Each of the locking portions 43a, 43b, and 43c has an
inclined face for guiding the anchoring portion 28 that increases
in its projected width from its distal side to its proximal side;
and an orthogonal face disposed at the rear end portion of the
annular inclined face and being orthogonal to the groove. The
orthogonal face and the anchoring portion 28 are locked to each
other.
[0089] The pulling member 25 has a linear portion 26. As in the
case of the above-described embodiment the linear portion 26 has a
holding portion formed at the distal end thereof to hold the
pulling member 25 at the first cylindrical part 2. As shown in FIG.
8, the linear portion 26 of the pulling member 25 extends to the
outside from the side hole 23 of the first cylindrical part 2,
penetrates into the second cylindrical part 3 from the distal-side
side hole 31 of the second cylindrical part 3, extends inside the
second cylindrical part 3, extends to the outside from the
proximal-side side hole 32 of the second cylindrical part 3, and
penetrates into the third cylindrical part 4 from the distal-side
side hole 41 of the third cylindrical part 4. The proximal portion
of the pulling member 25 (linear portion 26) extends to the outside
of the third cylindrical part 4 from the distal-side side hole 42
of the third cylindrical part 4 and penetrates into the groove 4d
formed on the side face of the third cylindrical part 4. The
anchoring portion 28 is mounted at the proximal end of the pulling
member 25 (linear portion 26). An annular portion 29 to be
connected to the pulling wire 8 is provided on the anchoring
portion 28.
[0090] As shown in FIGS. 9 and 10, the groove 4d formed on the side
faces of the third cylindrical part 4 has axially extending linear
ribs 4e formed on opposed portions of an outer surface of the third
cylindrical part 4. As shown in FIGS. 9 and 10, the anchoring
portion 28 has a base portion 28a which is slidable inside the
groove 4d of the third cylindrical part 4 and is restrained from
being separated from the groove 4d by the rib 4e and an
anchor-constructing portion 28b formed on the outer surface of the
base portion 28a. In this embodiment the anchor-constructing
portion 28b is constructed of a rib circularly projected. The
anchor-constructing portion 28b does not necessarily have to be
circular but may be elliptic or polygonal.
[0091] The locking portion 43 to which the anchor-constructing
portion 28b of the anchoring portion 28 is locked is formed on the
groove 4d of the third cylindrical part 4. In this embodiment, the
locking portions 43a, 43b, and 43c are provided at certain
intervals along the axial direction of the groove 4d. Each of the
locking portions 43a, 43b, and 43c is constructed of opposed ribs.
In this embodiment, each of the locking portions 43a, 43b, and 43c
is constructed of opposed ribs approximately triangular. The rib
constructing the locking portions is formed integrally with the rib
4e. In this embodiment, each of the locking portions 43a, 43b, and
43c has an inclined portion, for guiding the anchor-constructing
portion 28b, which inclines in a central direction of the groove
from its distal side to its proximal side; and a
locking/unlocking-guiding inclined portion which is continuous with
the rear end of the annular inclined surface and inclines in the
direction of the side face of the groove from its distal side to
its proximal side. The locking/unlocking-guiding inclined surface
and the anchor-constructing portion 28b are locked to each
other.
[0092] The pulling wire 8 extends between the inner tube 7 and the
outer tube 6. The proximal portion of the pulling wire 8 extends to
the outside from the proximal end of the outer tube 6. The pulling
wire 8 is separable from the pulling member. More specifically, as
shown in FIG. 9, the pulling member 25 of the device 13 has the
annular portion 29 at its proximal portion. The pulling wire 8 is
folded back after it penetrates through the annular portion 29.
That is, the looped portion 81 of the pulling wire 8 is in
penetration through the annular portion 29. By pulling the pulling
wire 8 (exactly, two wires), the pulling member 25 is pulled to the
proximal side of the apparatus 40. The operation portion 82 is
mounted at the proximal end (proximal end of two wires) of the
pulling wire 8. The pulling wire 8 is made of a material which can
be cut Alternatively the operation portion 82 can be removed from
the pulling wire 8. Therefore by cutting the pulling wire 8 or
removing the operation portion 82 from the pulling wire 8, the end
of the pulling wire 8 is formed or exposed. By pulling the pulling
wire 8, the pulling wire 8 can be separated from the pulling member
25.
[0093] The apparatus 40 has the unlocking mechanism for releasing
locking performed by the locking mechanism of the device 13. In the
apparatus 40, a groove extending axially is formed on the side face
of the inner tube 7 in correspondence with the groove 4d of the
third cylindrical part 4. Similarly to the groove 4d, this groove
has axially extending linear ribs formed on opposed portions of the
outer surface of the inner tube 7. The linear ribs may be composed
of dotted ribs. The unlocking mechanism is constructed of the
unlocking shaft 29. The unlocking shaft 29 extends through the
groove formed on the side face of the inner tube 7 and penetrates
into the groove 4d from the proximal portion of the third
cylindrical part 4. The distal portion of the unlocking shaft 29 is
disposed in the vicinity of the locking portion 43. To unlock the
anchoring portion 28 of the pulling member 25 from the locking
portion 43, the unlocking shaft 29 is pressed to press the
anchoring portion 28 toward the distal side. The unlocking shaft 29
is removed when there is no need of unlocking the anchoring portion
28 from the locking portion 43.
[0094] In the apparatus 40 of this embodiment as shown in FIG. 18,
after the device 13 is disposed at the foramen ovale, the pulling
member 25 is pulled. Thereby the first connection portion 21 and
the second connection portion 22 are bent Consequently the proximal
portion of the first cylindrical part 2 and the distal portion of
the second cylindrical part 3 become proximate to each other, and
the proximal portion of the second cylindrical part 3 and the
distal portion of the third cylindrical part 4 become also
proximate to each other. As a result, the device 13 deforms into a
configuration similar to a letter Z. By further pulling the pulling
member 25, the anchoring portion 28 passes through the locking
portion 43 (for example, locking portion 43a) and is locked
thereto, as shown in FIG. 9. Thereby the device 13 keeps the
configuration similar to the letter Z. In this manner, as shown in
FIG. 18, the first cylindrical part 2 and the second cylindrical
part 3 hold a distal portion 102 of the flap of the septum primum,
and the second cylindrical part 3 and the third cylindrical part 4
hold an upper portion 103 of the interatrial septum where the
foramen ovale is present Thereby the flap 102 is restrained from
opening toward the left atrium of heart.
[0095] Similarly to the embodiment described above with reference
to FIGS. 4 and 5, in the device 13 of this embodiment, each
cylindrical part does not necessarily have to be provided with the
connection portion. In this case, it is preferable to form opposed
inclined faces at portions of opposed end faces of each cylindrical
part, similarly to the above-described embodiment described above
with reference to FIGS. 4 and 5.
[0096] Like an apparatus 50 shown in FIG. 11, the apparatus having
the locking mechanism whose construction is as shown in FIGS. 8
through 10 may have an unlocking mechanism of the apparatus shown
in FIGS. 1 through 3. The unlocking mechanism of the apparatus 50
is constructed of the unlocking wire 9 having a loop 91 disposed in
the apparatus 50. The pulling member 25 of the device or the
pulling wire 8 thereof is in penetration through the loop 91 of the
unlocking wire 9. Thus by pulling the unlocking wire 9 toward the
proximal side of the device, with the anchoring portion 28 being
locked to the locking portion 43, the anchoring portion 28 is
forcibly passed through the locking portion 43 and is returned to
the distal side of the third cylindrical part 4. Thereby the
anchoring portion 53 and the locking side-hole 42 are unlocked from
each other. The operation portion 92 is mounted at the proximal end
(proximal end of two wires) of the unlocking wire 9. The unlocking
wire 9 is made of a material which can be cut Alternatively the
operation portion 92 can be removed from the unlocking wire 9.
Therefore by cutting the unlocking wire 9 or removing the operation
portion 92 from the unlocking wire 9, the end of the unlocking wire
9 is formed or exposed. By pulling the unlocking wire 9, the
unlocking wire 9 can be separated from the pulling member or the
pulling wire.
[0097] The method of using the apparatus having the device of the
present invention is described below with reference to FIGS. 12
through 17.
[0098] As shown in FIG. 12, the apparatus 10 is inserted into the
femoral vein. Thereafter a guide wire 100 is inserted into the
apparatus 10 to insert the apparatus 10 into the lower large vein
and the right atrium of heart along the guide wire 100. Then the
distal portion of the guide wire 100 is passed through a foramen
ovale 101 of the interatrial septum. Thereafter as shown in FIG.
13, the device 1 is pressed out of the distal end of the outer tube
6 of the apparatus 10 along the guide wire 100 to dispose the first
cylindrical part 2 at the left atrium of heart with respect to the
septum primum and dispose the second cylindrical part 3 at the
foramen ovale. Then with the inner tube 7 maintained at its
original position, the outer tube 6 is pulled toward its proximal
side to expose the third cylindrical part 4 inside the right atrium
of heart as shown in FIG. 14. After the entire device 1 is exposed
in the heart the pulling wire 8 is pulled. As a result as shown in
FIG. 15, the proximal portion of the first cylindrical part 2 and
the distal portion of the second cylindrical part 3 become
proximate to each other, and the proximal portion of the second
cylindrical part 3 and the distal portion of the third cylindrical
part 4 become also proximate to each other. Consequently the device
1 deforms into a configuration similar to the letter Z. More
specifically describing, as shown in FIG. 16, by pulling the
pulling wire 8 toward the proximal side of the apparatus 10, the
pulling member 5 is pulled. Thereby the first connection portion 21
and the second connection portion 22 are bent Consequently the
proximal portion of the first cylindrical part 2 and the distal
portion of the second cylindrical part 3 become proximate to each
other, and the proximal portion of the second cylindrical part 3
and the distal portion of the third cylindrical part 4 become also
proximate to each other. As a result, the device 1 deforms into the
configuration similar to the letter Z. By keeping pulling the
pulling member 8, the anchoring portion 53 passes through the
locking side-hole 42 and is locked thereto, as shown in FIG. 16.
Thereby the device 1 keeps the deformed configuration similar to
the letter Z. In this manner, the first cylindrical part 2 and the
second cylindrical part 3 hold a distal portion 102 of the flap of
the septum primum, and the second cylindrical part 3 and the third
cylindrical part 4 hold an upper portion 103 of the interatrial
septum where the foramen ovale is present Thereby the flap 102 is
restrained from opening toward the left atrium of heart When the
operator desires to decrease the distance between the distal
portion of the first cylindrical part 2 and the proximal portion of
the second cylindrical part 3 and the distance between the distal
portion of the second cylindrical part 3 and the proximal portion
of the third cylindrical part 4, the pulling wire 8 is pulled
further. Thereby the anchoring portions 54 and 55 pass through the
locking side-hole 42 and are locked thereto. Thereby the device 1
keeps the deformed configuration similar to the letter Z.
[0099] When the anchoring portion (for example, the anchoring
portion 53) is desired to be unlocked from the locking side-hole
42, the unlocking wire 9 is pulled to the proximal side of the
apparatus 10. Thereby as shown in FIG. 17, the proximal portion of
the pulling member 5 is pulled toward the third cylindrical part 4,
and the anchoring portion (for example, the anchoring portion 53)
passes through the locking side-hole 42, thus penetrating into the
third cylindrical part 4. Thereby both are unlocked from each
other.
[0100] When an object is achieved because the anchoring portion 53
has been locked to the locking side-hole 42 and because the
deformed state of the device 1 similar to the letter Z has been
obtained, the pulling wire 8 is cut at a position outward from the
proximal end of the apparatus 10 and pulled out. The unlocking wire
9 is also cut at a position outward from the proximal end of the
apparatus 10 and pulled out Thereafter the apparatus 10 (outer tube
6 and inner tube 7) is pulled out of the organism, together with
the guide wire 100.
[0101] The device of the present invention for treating the patent
foramen ovale has the first part having the predetermined length;
the second part having the predetermined length; the third part
having the predetermined length; and the pulling member whose
proximal end penetrates into the second part from the side face of
the distal portion of the second part crosses the second
cylindrical part obliquely and extends from the side face of the
proximal portion of the second part and penetrates or is penetrable
into the third part from the side face of the distal portion of the
third part with the distal end of the pulling member held by the
proximal portion of the first part A part of the locking mechanism
provided at the proximal portion of the pulling member and a part
of the locking mechanism provided at the third part are locked to
each other, when the pulling member is pulled to allow the first
part and the second part to be proximate to each other and the
second part and the third part to be proximate to each other.
[0102] By pulling the pulling member, the proximal portion of the
first cylindrical part and the distal portion of the second
cylindrical part become proximate to each other, and the proximal
portion of the second cylindrical part and the distal portion of
the third cylindrical part become also proximate to each other. As
a result the device deforms into the configuration similar to the
letter Z. The locking mechanism maintains the configuration. In
this manner, the first cylindrical part and the second cylindrical
part hold the distal portion of the flap of the septum primum, and
the second cylindrical part and the third cylindrical part hold the
upper portion of the interatrial septum where the foramen ovale is
present Thereby the flap is restrained from opening toward the left
atrium of heart, and blood is prevented from flowing from the right
atrium of heart to the left atrium of heart in spite of the patent
foramen ovale. In the device of the present invention, a spring
action is not utilized, but the straight members are mechanically
bent or folded to hold the distal end of the flap of the septum
primum and the open portion of the foramen ovale. Therefore they
are little damaged and a load is applied little thereto.
[0103] A device and an apparatus of another embodiment of the
present invention for treating the patent foramen ovale are
described below with reference to the drawings.
[0104] FIG. 19 is a front view of a device of another embodiment of
the present invention for treating the patent foramen ovale. FIG.
20 is a rear view of the device shown in FIG. 19. FIG. 21 is a
right side view of the device shown in FIG. 19. FIG. 22 is a side
view of a device of another embodiment of the present invention for
treating the patent foramen ovale. FIG. 26 is an explanatory view
for explaining an example of a deformed state holding member of the
device of the present invention for treating the patent foramen
ovale. FIG. 27 is an explanatory view for explaining another
example of the deformed state holding member of the device of the
present invention for treating the patent foramen ovale.
[0105] A device 200 of this embodiment for treating the patent
foramen ovale is used to treat the foramen ovale formed on the
septum in the organism. As shown in FIGS. 19 through 21 and 25, the
device 200 includes a first part 201 having a predetermined length
and a through-passageway 121 provided at a proximal side thereof; a
second part 202 having a predetermined length and a
through-passageway 122; a third part 203 having a predetermined
length and a through-passageway 123 provided at a distal side
thereof; a pulling member 104, one end of which is held by the
first part 201 and which is extended sequentially in penetration
through the through-passageway 121 of the first part 201, the
through-passageway 122 of the second part 202, and the
through-passageway 123 of the third part 203; and a deformed state
holding member 105, provided at other side of the pulling member
104, for holding the device 200 deformed into an approximately Z
configuration, in a side view, which is formed by approach or
contact of a side face of a proximal portion of the first part 201
to or with a side face of a distal portion of the second part 202
at one side thereof and approach or contact of a side face of a
proximal portion of the second part 202 at other side thereof to or
with a side face of a distal portion of the third part 203 owing to
pulling of the pulling member 104.
[0106] An apparatus 110 of this embodiment for treating the patent
foramen ovale has an outer tube 140, the device 200, an inner tube
141, and a pulling wire 148.
[0107] In the device 200 of this embodiment the second part 202 can
be bent at the proximal portion of the first part 201, and the
third part 203 can be bent at the proximal portion of the second
part 202. Although the above-described construction is preferable
in this embodiment, the first part, the second part, and the third
part may be separate like the device 1 of the above-described
embodiment
[0108] More specifically, as shown in the drawings, the device 200
of this embodiment has an integrally formed body member having the
first part 201, the second part 202, and the third part 203. The
body member has a first connection portion 131a bendably connecting
the first part 201 and the second part 202 with each other and a
second connection portion 132a bendably connecting the second part
202 and the third part 203 with each other.
[0109] It is preferable that the first part 201 branches with two
branched portions spread out toward its distal side and that the
two branched portions can be approached to each other. More
specifically, as shown in FIG. 19, the first part 201 branches at a
portion of its proximal side to form a shape similar to that of a
letter "Y". The branched portion of the first part 201 is made of
an elastically deformable material. Thereby the first part 201 can
be accommodated in the outer tube 140 with the two branched
portions proximate to each other. After the first part 201 is
discharged from the outer tube 140, it is capable of returning to
the original shape similar to that of the letter "Y". The first
part 201 may be entirely made of the elastically deformable
material or only the branched portion may be made of the
elastically deformable material. Instead of making the branched
portion of the elastically deformable material, the branched
portion may be opened and closed mechanically.
[0110] Similarly to the first part 201, it is preferable that the
third part 203 branches with two branched portions spread out
toward its proximal side and that the two branched portions can be
approached to each other. More specifically, as shown in FIG. 19,
the third part 203 branches at a portion of its distal side to form
a shape similar to that of the inverted letter "Y". The branched
portion of the third part 203 is made of the elastically deformable
material. Thereby the third part 203 can be accommodated in the
outer tube 140 with the two branched portions proximate to each
other. After the third part 203 is discharged from the outer tube
140, it is capable of returning to the original shape similar to
that of the inverted latter "Y". The third part 203 may be entirely
made of the elastically deformable material or only the branched
portion may be made of the elastically deformable material. Instead
of making the branched portion of the elastically deformable
material, the branched portion may be opened and closed
mechanically.
[0111] As shown in FIG. 19 and 21, the device 200 of this
embodiment has a slit 131 forming a boundary between the first part
201 and the second part 202. As shown in FIGS. 19 and 21, the slit
131 is extended from a front surface of the device 200 toward a
rear surface thereof and does not reach the rear surface thereof.
Therefore a slit-unformed position of the slit-formed portion
constructs a connection portion 131a connecting the first part 201
and the second part 202 with each other. Similarly, as shown in
FIGS. 20 and 21, a slit 132 is extended from the rear surface of
the device 200 toward the front surface thereof and does not reach
the front surface thereof. Therefore the slit-unformed position of
the slit-formed portion constructs a connection portion 132a
connecting the second part 202 and the third part 203 with each
other.
[0112] Therefore as shown in FIG. 25, in the device 200 of this
embodiment, by pulling the pulling member 104, the first part 201
bends about the second part 202 at the slit 131, and the third part
203 bends about the second part 202 at the slit 132 in a direction
opposite to the bent direction of the first part 201. As a result,
the device 200 forms a shape similar to that of a letter "N" in a
side view. The device 200 may be so constructed that when the
device 200 is bent, the first part may be fractured from the second
part and that the third part may be fractured from the second part
In this case, the connection portion is not formed.
[0113] As shown in FIGS. 21 and 25, it is preferable to chamfer a
corner 201c of the portion in which the slit 131 is formed (the
corner of the portion in which the slit 131 of the first part 201
is formed) and a corner 202a (the corner of the portion in which
the slit 131 of the second part 202 is formed) confronting the
corner 201c. It is also preferable to chamfer a corner 202b of the
portion in which the slit 132 is formed (the corner of the portion
in which the slit 132 of the second part 202 is formed) and a
corner 203c (the corner of the portion in which the slit 132 of the
third part 203 is formed) confronting the corner 202b. Thereby as
shown in FIG. 25, the exposed corners are not edged when the
pulling member is pulled. Thus it is possible to restrain the
device 200 from damaging an inner wall of the organism.
[0114] In this embodiment, the first part 201, the second part 202,
and the third part 203 are pillar-shaped. Although it is preferable
that they are pillar-shaped, they may be cylindrical like the first
part 201, the second part 202, and the third part 203 of the
above-described embodiment.
[0115] It is preferable that the through-passageway 122 of the
second part 202 is disposed at the central side of the second part
202 in its longitudinal direction.
[0116] The pulling member 104 is held at its one end by the first
part 201 and extended sequentially through the through-passageway
121 of the first part 201, the through-passageway 122 of the second
part 202, and the through-passageway 123 of the third part 203.
[0117] In this embodiment, one end of the pulling member 104 is
held by the first part 201 at its distal portion. In this
embodiment, the pulling member 104 is constructed of a first
pulling member 111 held at the distal portion of each of the two
branched portions of the first part 201, and a second pulling
member 112 which is capable of pulling the proximal side of the
first pulling member 111 and extended sequentially in penetration
through the through-passageway 121 of the first part 201, the
through-passageway 122 of the second part 202, and the
through-passageway 123 of the third part 203.
[0118] The first pulling member 111 is a linear wire having two
distal portions each of which is held by the distal portion of the
each of the two branched portions of the first part 201. This
construction allows the branched configuration of the first part
201 to be securely accomplished by pulling the first pulling member
111. In this embodiment, distal portions of the first pulling
member 111 penetrate through holes 201a, 201b respectively formed
at distal portions of the first part 201. Anchoring portions 109a,
109b are fixed to the distal portions of the first pulling member
111 respectively. Thereby each distal portion of the first pulling
member 111 is held by the first part 201.
[0119] The second pulling member 112 is a looped linear wire. The
looped distal portion of the second pulling member 112 is
positioned in proximity to the proximal portion of the first part
and the first pulling member 111, penetrates through the
through-passageway 121 of the first part 201, is extended to the
proximal side of the second part 202 along the rear surface of the
device, penetrates through the through-passageway 122 of the second
part 202, appears on the front surface of the device, penetrates
through the through-passageway 123 of the third part 203, and is
extended to the rear surface of the device.
[0120] The proximal side of the first pulling member 111 can be
pulled by pulling the second pulling member 112. The pulling member
104 has a linking member 106 linking the first pulling member 111
and the second pulling member 112 with each other. As the linking
member 106, a material having a through-passageway through which
the first pulling member 111 and the second pulling member 112
penetrate is used. More specifically, the linking member 106 is
composed of a bead member having a through-passageway. The linking
member 106 may be composed of members having any configurations
cylindrical, ring-shaped, and the like provided that they have a
through-passageway. Instead of providing the pulling member 104
with the linking member, the first pulling member 111 and the
second pulling member 112 may be intersected with each other at the
proximal portion of the first pulling member 111 or the first
pulling member 111 and the second pulling member 112 may be joined
with each other at the proximal portion of the first pulling member
111.
[0121] The pulling member 104 may be composed of one member instead
of being composed of the first pulling member 111 and the second
pulling member 112
[0122] It is preferable that in this embodiment, as shown in FIG.
19, the third part 203 has a second through-passageway 124 disposed
at the proximal side thereof with respect to the through-passageway
123 formed at the distal side of the third part 203. It is
preferable that the device 200 has a linear wire 113 for said third
part having a distal-side portion looped at a portion, of said
pulling member, which is disposed between the through-passageway
123 of the third part 203 and the deformed state holding member and
a proximal side portion which penetrates through the second
through-passageway 124 of the third part 203 and is held at a
proximal portion of the third part 203. The pulling member 104 (the
second pulling member 112) may be so constructed that the two
linear wires constructing the pulling member 104 pass through the
looped distal portion of the linear wire 113 for the third part 203
or only one of the two linear wires constructing the pulling member
104 (the second pulling member 112) passes through the looped
distal portion of the linear wire 113 for the third part 203. In
this embodiment the proximal portions of the linear wire 113 for
the third part penetrate through holes 203a, 203b respectively
formed at the proximal portions of the third part 203. Anchoring
portions 107a, 107b are fixed to the proximal portions of the
linear wire 113 for the third part respectively. Thereby each
distal portion of the linear wire 113 for the third part is held by
the third part 203. A ring-shaped member is used for the anchoring
portions 107a, 107b.
[0123] This construction allows the linear wire 113 for the third
part to be pulled when the deformed state holding member 105 which
is described later is operated. Thereby the branched configuration
of the third part 203 can be securely accomplished.
[0124] As shown in FIG. 26, it is preferable that the deformed
state holding member 105 has a through-passageway 161 through which
the pulling member (the second pulling member 112) can be slidably
penetrated at a predetermined resistance. That is, the deformed
state holding member 105 is capable of sliding along the second
pulling member 112 by being pressed rearward or forward at a degree
of force higher than the predetermined degree of force. In a normal
state, the deformed state holding member 105 is not moved because
it is subjected to the fictional resistance of the pulling member
and that of the inner surface of the through-passageway. It is
preferable that the through-hole 161 has a diameter-enlarged
portion 162 into which the pulling member is inserted. It is
preferable that the deformed state holding member 105 is composed
of a sphere.
[0125] As shown in FIG. 27, the device 200 may have an anchoring
portion 114 provided at the other side (proximal side) of the
pulling member 104 (the second pulling member 112). A deformed
state holding member 105a may have a through-hole 161a through
which the pulling member 104 (the second pulling member 112)
penetrates and a locking portion 163 capable of locking the
anchoring portion 114 thereto so that the pulling member is capable
of sliding through the through-hole 161a. In this embodiment the
second pulling member 112 slides through the through-passageway
161a without being subjected to a resistance. In this embodiment
the locking portion 163 is constructed of an annular rib formed
inside the through-hole 161a. The anchoring portion 114 is composed
of a sphere. The anchoring portion 114 has an outer diameter a
little larger than a minimum inner diameter of the annular rib 163.
The anchoring portion 114 and the locking portion (annular rib) 163
are locked to each other, when the pulling member (second pulling
member 112) is pulled and the anchoring portion 114 rides across
the annular rib 163. Thereby the anchoring portion 114 is
restrained from moving to the distal side of the anchoring portion
114, and a deformed state of the device is maintained. As shown in
FIG. 27, it is preferable to form a plurality of the anchoring
portions 114. Thereby the deformed state of the device can be
selected.
[0126] The first part 201, the second part 202, and the third part
203 of the device 20 may be circular, elliptic, polygonal, and the
like in the sectional configuration thereof. The width and outer
diameter of the material for forming each of the first part 201,
the second part 202, and the third part 203 is favorably in the
range of 0.1 to 5.0 mm and more favorably in the range of 1.0 to
3.0 mm. Tie longitudinal length of the first part 201 is favorably
in the range of 5 to 50 mm. The longitudinal length of the second
part 202 is favorably in the range of 5 to 50 mm. The longitudinal
length of the third part 203 is favorably in the range of 5 to 50
mm. The distance between the distal ends of the branched portions
of the first part 201 is favorably in the range of 10 to 40 mm. The
distance between the proximal ends of the branched portions of the
third part 203 is favorably in the range of 10 to 40 mm. In the
device 200 of this embodiment, the longitudinal length of the third
part 203 is set larger than that of the first part and that of the
second part Thereby the flap of the septum primum can be held
securely. It is preferable that the longitudinal length of the
third part 203 is set longer than that of the second part.
[0127] As the material for forming each part (first part, second
part, and third part) of the device, in consideration of
flexibility, hardness, strength, sliding property, kink resistance,
and stretching property, it is preferable to selectively use
polymers such as polyethylene, polypropylene, nylon, polyethylene
terephthalate, fluorine-containing polymers (for example, PTFE,
ETFE); and thermoplastic elastomers. The thermoplastic elastomer is
used selectively from synthetic resin of nylon family (for example,
polyamide elastomer), urethane family (for example, polyurethane
elastomer), polyester family (for example, polyethylene
terephthalate elastomer), and olefin family (for example,
polyethylene elastomer, polypropylene elastomer). As described
above, it is preferable that the branched portion of the first part
201 and that of the third part 203 are made of an elastically
deformable material. As the elastically deformable material, the
above-described resins can be used. The thermoplastic elastomer is
most favorable. In the device, by using a two-color molding method,
the branched portion of the first part 201 and that of the third
part 203 of the body member may be made of the above-described
elastomer, and the other parts may be made of resin compatible with
the elastomer and having a hardness than that of the elastomer by
using a two-color molding method. Although it is preferable that
the branched portion of the first part 201 and that of the third
part 203 are made of the elastically deformable material, the
branched portions may be made of a plastically deformable material
because when the first pulling member and the linear wire for the
third part are pulled, the branched portion of the first part 201
and that of the third part 203 are restored to the original
configuration thereof similar to that of Y.
[0128] It is preferable to treat the inner surface of the
through-passageway of each of the first, second, and third parts to
enhance the sliding property of the pulling member. As such
treatment, it is possible to adopt a method of applying or fixing
the following hydrophilic polymers to the inner surface thereof
poly(2-hydroxyethyl methacrylate), polyhydroxyethy acrylate,
hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride
copolymer, polyethylene glycol, polyacryl amide, and polyvinyl
pyrrolidone. To enhance the sliding property of the inner surface
of the outer tube and/or the outer surface of the inner tube, these
hydrophilic polymers may be applied or fixed thereto.
[0129] As the material for forming the linear portion of the
pulling member and the linear wire for the third part, it is
possible to use metals such as stainless steel, Ni--Ti alloy,
Cu--Zn alloy, Ni--Al alloy, tungsten, tungsten alloy, titanium,
titanium alloy, cobalt alloy, tantalum; comparatively rigid
polymeric materials such as polyamide, polyimide,
ultra-high-molecular-weight polyethylene, polypropylene,
fluororesin; and a combination of these materials. As the linear
portion 111, 112, 113, a wire or a plurality of twisted wires can
be preferably used. Although not specifically limited, the diameter
of the linear portion is favorably in the range from 0.01 mm to 1.3
mm and more favorably in the range from 0.1 mm to 0.3 mm.
[0130] Like a device 210 shown in FIG. 22, a through-hole formed in
penetration through the first part 201, second part 202, and the
third part 203 may be formed obliquely to reduce a resistance to
the movement of the pulling member in the pulling direction. More
specifically, a through-hole 121a of the first part 201 is formed
obliquely toward the proximal side of the first part 201 from the
front surface of the body member of the device 210 to the rear
surface thereof. A through-hole 122a of the second part 202 is
formed obliquely toward the proximal side of the second part 202
from the rear surface of the body member of the device 210 to the
front surface thereof. A through-hole 123a of the third part 203 is
formed obliquely toward the proximal side of the third part 203
from the front surface of the body member of the device 210 to the
rear surface thereof. A second through-hole 124a of the third part
203 is formed obliquely toward the proximal side of the third part
203 from the rear surface of the body member of the device 210 to
the front surface thereof.
[0131] An apparatus for treating the patent foramen ovale of
another embodiment of the present invention is described below with
reference to FIGS. 23 through 25.
[0132] FIG. 23 shows an outlook of the apparatus having the device
shown in FIG. 19. FIG. 24 is a partly omitted enlarged sectional
view of the apparatus shown in FIG. 23. FIG. 25 is an explanatory
view for explaining the operation of the apparatus shown in FIGS.
23 and 24.
[0133] The apparatus 110 of this embodiment for treating the patent
foramen ovale is used to treat the foramen ovale formed on the
septum in the organism. As shown in FIGS. 23 and 24, the apparatus
110 has an outer tube 140, the device 200 accommodated inside a
distal portion of the outer tube 140 with the device 200 kept
almost straight, an inner tube 141 for pressing the device 200 out
of the distal end of the outer tube 140 and operating the deformed
state holding member 105, and the pulling wire 148 which is capable
of pulling the pulling member 104 and separable from the pulling
member 104.
[0134] As shown in FIGS. 23 and 24, the outer tube 140 is tubular.
The outer tube 140 is open at its distal and proximal ends. The
opening formed at the distal end of the outer tube 140 functions as
a release opening when the device 200 is retained in a foramen
ovale. The distal portion of the outer tube 140 serves as an
accommodation portion for accommodating the device 200 therein when
the device 200 is straight.
[0135] The outer diameter of the outer tube 140 is favorably in the
range from 0.3 mm to 7.0 mm and more favorably in the range from
1.2 mm to 5.0 mm. The inner diameter of the outer tube 140 is
favorably in the range from 0.2 mm to 6.5 mm. The length of the
outer tube 140 is favorably in the range from 300 mm to 2000 mm and
more favorably in the range from 700 mm to 1500 mm.
[0136] As shown in FIGS. 23 and 24, the inner tube 141 is tubular.
The inner tube 141 is open at its distal and proximal ends. The
inner tube 141 is accommodated in the outer tube 140. The distal
portion of the inner tube 141 is capable of contacting the proximal
portion of the device 200. Thus the inner tube 141 is capable of
pressing the device 200 from the distal end of the outer tube 140.
As shown in FIG. 24, in the apparatus 110 of this embodiment, the
distal portion of the inner tube 141 contacts the deformed state
holding member 105 and the deformed state holding member 105 to be
operated. The apparatus 110 has a pulled state release member for
releasing a deformation state held by the deformed state holding
member 105 of the device 200.
[0137] The outer diameter of the inner tube 141 is favorably in the
range from 0.1 mm to 5.0 mm and more favorably in the range from
1.0 mm to 3.0 mm. The inner diameter of the inner tube 141 is
favorably in the range from 0.05 mm to 4.8 mm. The length of the
inner tube 141 is favorably in the range from 300 mm to 2000 mm and
more favorably in the range from 700 mm to 1500 mm.
[0138] As the material for forming the outer tube 140 and the inner
tube 141, in consideration of properties (flexibility, hardness,
strength, sliding property, kink resistance, and stretching
property) demanded for them, it is preferable to selectively use
polymers such as polyethylene, polypropylene, nylon, polyethylene
terephthalate, fluorine-containing polymers (for example, PTFE,
ETFE); and thermoplastic elastomers. The thermoplastic elastomer
includes synthetic resin of nylon family (for example, polyamide
elastomer), urethane family (for example, polyurethane elastomer),
polyester family (for example, polyethylene terephthalate
elastomer), olefin family (for example, polyethylene elastomer,
polypropylene elastomer).
[0139] It is preferable to treat the outer surface of the outer
tube 140 to enhance the sliding property thereof. As such treatment
it is possible to adopt a method of applying or fixing the
following hydrophilic polymers to the inner surface thereof:
poly(2-hydroxyethyl methacrylate), polyhydroxyethy acrylate,
hydroxypropyl cellulose, methyl vinyl ether-maleic anhydride
copolymer, polyethylene glycol, polyacryl amide, and polyvinyl
pyrrolidone. To enhance the sliding property of the inner surface
of the outer tube and/or the outer surface of the inner tube, these
hydrophilic polymers may be applied or fixed thereto.
[0140] The pulling wire 148 is folded back after it penetrates
through a looped portion or an annular portion formed at the
proximal portion of the pulling member 104 (the second pulling
member 112) of the device 200. In this embodiment, as shown in FIG.
24, the distal portion of the pulling wire 148 is folded back
inside the outer tube 140 after it penetrates through the looped
portion or the annular portion formed at the proximal portion of
the second pulling member 112 and is then penetrated into the inner
tube 141 from the opening disposed at the distal end of the inner
tube 141. Thereafter the distal portion of the pulling wire 148 is
exposed to the outside from the proximal end of the inner tube 141.
That is, the pulling wire 148 is extended to its proximal side with
two wires kept in parallel after it (one wire) is folded back at
its distal portion. By pulling the pulling wire 148 (exactly, two
wires), the pulling member 104 (the second pilling member 112) is
pulled to the proximal side of the device 200. An operation portion
148a is mounted at the proximal end (proximal end of two wires) of
the pulling wire 148. The pulling wire 148 is made of a material
which can be cut Alternatively the operation portion 148a can be
removed from the pulling wire 148. Therefore by cutting the pulling
wire 148 or removing the operation portion 148a from the pulling
wire 148, the end of the pulling wire 148 is formed or exposed. By
pulling the pulling wire 148, the pulling wire 148 can be separated
from the pulling member 104. An annular portion may be formed on
the proximal end of the pulling member 112 by mounting an annular
member thereon instead of forming the looped portion thereon.
[0141] The apparatus 110 of this embodiment has a pulled state
release member 108 which is pulled to move the deformed state
holding member 105 to the other side (proximal side) of the pulling
member 104.
[0142] The device 200 of the apparatus 110 of this embodiment has
the second through-passageway 124 disposed at the proximal side of
the third part 203 with respect to the through-passageway 123
formed at the distal side of the third part 203, and the
distal-side portion looped at the portion, of the pulling member
104, which is disposed between the through-passageway 123 of the
third part 203 and the deformed state holding member 105. The
device 200 further includes the linear wire 113, for the third part
203, which penetrates through the second through-passageway 124 of
the third part 203 and has the proximal side portion held by the
third part 203 at the proximal portion thereof. The pulled state
release member 108 is constructed of a linear wire for pulling a
portion, of the linear wire 113 for the third part, which is held
by the third part 203 at the proximal portion thereof.
[0143] More specifically, as described above, in the device 110 of
this embodiment, the third part 203 is provided with the linear
wire 113. The proximal portions of the linear wire 113 for the
third part penetrate through the holes 203a, 203b respectively
formed at the proximal portions of the third part 203. The
anchoring portions 107a, 107b are fixed to end portions of the
linear wire 113 for the third part respectively. The ring-shaped
member is used for the anchoring portions 107a, 107b. The linear
wire 113 for the third part extends to the distal side of the
device 200 in penetration through the second through-passageway 124
of the third part 203. The distal portion of the linear wire 113
for the third part loops at the portion, of the pulling member 104,
which is disposed between the through-passageway 123 of the third
part 203 and the deformed state holding member 105.
[0144] In the apparatus 110 of this embodiment, the pulled state
release member 108 is composed of the looped wire (pulled state
release wire) penetrating through the ring-shaped anchoring
portions 107a, 107b of the linear wire 113 for the third part.
[0145] More specifically, the pulled state release wire 108 is
folded back after it penetrates through the ring-shaped anchoring
portions 107a, 107b of the linear wire 113 for the third part of
the device 200. As shown in FIG. 19, in this embodiment the pulled
state release wire 108 is folded back at its distal portion after
it penetrates through the ring-shaped anchoring portions 107a, 107b
and is then penetrated into the inner tube 141 from the opening
disposed at the distal end thereof. Thereafter the pulled state
release wire 108 is exposed to the outside from the proximal end of
the inner tube 141. That is, the pulled state release wire 108 is
extended to its proximal side with two wires kept in parallel after
it (one wire) is folded back at its distal portion. By pulling the
pulled state release wire 108 (exactly, two wires), the linear wire
113 for the third part is pulled. Thereby the deformed state
holding member 105 can be moved to the proximal side of the pulling
member 104 (second pulling member 112) by means of the looped
distal portion of the linear wire 113 for the third part Owing to
the movement of the deformed state holding member 105 to the
proximal side of the pulling member 104 (second pulling member
112), the deformation-held state is released. An operation portion
149 is mounted at the proximal end (proximal end of two wires) of
the pulled state release wire 108. The pulled state release wire
108 is made of a material which can be cut Alternatively the
operation portion 149 may be removed from the pulled state release
wire 108. Therefore by cutting the pulled state release wire 108 or
removing the operation portion 149 from the pulled state release
wire 108, the end of the pulled state release wire 108 is formed or
exposed. By pulling the pulled state release wire 108, it can be
separated from the pulling member 104.
[0146] As the pulling wire and the unlocking wire, a wire or a
plurality of twisted wires can be preferably used. Although not
specifically limited, the diameter of the pulling wire and the
unlocking wire is favorably in the range from 0.01 mm to 1.3 mm and
more favorably in the range from 0.1 mm to 0.3 mm. As the material
for forming the pulling wire and the unlocking wire, it is possible
to use metals such as stainless steel, Ni--Ti alloy, Cu--Zn alloy,
Ni--Al alloy, tungsten, tungsten alloy, titanium, titanium alloy,
cobalt alloy, tantalum; comparatively rigid polymeric materials
such as polyamide, polyimide, ultra-high-molecular-weight
polyethylene, polypropylene, fluororesin; and a combination of
these materials.
[0147] As shown in FIGS. 2, 3, 16, and 17, like the device 1 of the
above-described embodiment, a contrast portion may be formed at the
distal portion of the first part 201. A contrast portion may be
formed at the distal portion of the second part and/or the proximal
portion thereof A contrast portion may be formed at the distal
portion of the third part 203 and/or the proximal portion thereof.
In the examples shown in FIGS. 2, 3, 16, and 17, the contrast
portions are formed at positions a little inward from the distal or
proximal ends of each of the first, second, and third parts, but
may be formed at the distal or proximal ends thereof.
[0148] The positions of these contrast portions can be checked by
X-ray contrast and ultrasonic wave contrast It is preferable to
compose the contrast portion of a ring-shaped wire or a coiled
linear wire. As the material of the contrast portion, gold,
platinum, tungsten, and alloys of these metals, a silver-palladium
alloy can be preferably used. The contrast portion may be made of
the same material as that used for the cylindrical members or a
combination of a contrast substance and a material compatible
therewith. As the contrast substance, it is possible to use X-ray
unpermeable materials such as barium sulfate, bismuth oxide, and
tungsten. A contrast portion (not shown) may be formed at the
distal portion of the outer tube 140. It is possible to form the
contrast portion at the distal portion of the outer tube 140 by a
method similar to the method of forming the above-described
contrast portions.
[0149] The method of using the apparatus having the device of the
above-described embodiments is described below with reference to
FIGS. 23 through 25.
[0150] As shown in FIGS. 12 through 15, the apparatus 110 is
inserted into the femoral vein. Thereafter a guide wire (not shown)
is inserted into the apparatus (between the outer tube 140 and the
inner tube 141) 110 to insert the apparatus 110 into the lower
large vein and then the right atrium of heart along the guide wire.
Then the distal portion of the guide wire is passed through a
foramen ovale of the interatrial septum. Thereafter the device 200
is pressed out of the distal end of the outer tube 140 of the
apparatus 110 to dispose the first part 201 at the left atrium of
heart with respect to the septum primum and dispose the second part
202 at the foramen ovale. Then with the distal position of the
inner tube 141 held at its original position, the outer tube 140 is
pulled toward its proximal side to expose the third part 203 inside
the right atrium of heart After the entire device 200 is exposed in
the heart, the pulling wire 148 is pulled. As a result, as shown in
FIG. 25, the deformed state holding member 105 contacts the distal
portion of the inner tube 141. By continuing to pull the pulling
wire 148, the deformed state holding member 105 moves to the distal
side of the pulling member (second pulling member 112). In a short
time, the first part 201 bends. As a result the proximal portion of
the first part 201 and the distal portion of the second part 202
become proximate to each other. Then the third part 203 bends. As a
result, the distal portion of the third part 203 and the proximal
portion of the second part 202 become proximate to each other.
Consequently the body member of the device 200 deforms into a
configuration similar to the letter "Z". The deformed state holding
member 105 remains disposed on the pulling member (second pulling
member 112), thereby keeping the device 200 deformed in the
configuration similar to the letter "Z". In this manner, the first
part 201 and the second part 202 hold the distal portion of the
flap of the septum primum, and the second part 202 and the third
part 203 hold an upper portion of the interatrial septum where the
foramen ovale is present Thereby the flap is restrained from
opening toward the left atrium of heart.
[0151] When an object is achieved in the deformed configuration of
the device 200 similar to the letter "Z", the pulling wire 148 is
cut at a position outward from the proximal end of the apparatus
110 and pulled out. Similarly, the pulled state release wire 108 is
also cut at a position outward from the proximal end of the
apparatus 110 and pulled out Thereafter the apparatus 110 (outer
tube 140 and inner tube 141) is pulled out of the organism,
together with the guide wire.
[0152] The device of the present invention for treating the patent
foramen ovale has the first part having the predetermined length;
the second part having the predetermined length; the third part
having the predetermined length; and the pulling member whose
proximal end penetrates into the second part from the side face of
the distal portion of the second part, crosses the second
cylindrical part obliquely and extends from the side face of the
proximal portion of the second part and penetrates or is penetrable
into the third part from the side face of the distal portion of the
third part, with the distal end of the pulling member held by the
proximal portion of the first part A part of the locking mechanism
provided at the proximal portion of the pulling member and a part
of the locking mechanism provided at the third part are locked to
each other, when the pulling member is pulled to allow the first
part and the second part to be proximate to each other and the
second part and the third part to be proximate to each other.
* * * * *